AB0509 CLINICAL EQUIVALENCE OF GENERIC AND BRANDED TOFACITINIB IN REAL-WORLD: A PROSPECTIVE LONGITUDINAL COHORT STUDY IN RHEUMATOID ARTHRITIS PATIENTS
Authors: J. Zhao, H. Huang, Z. Zhang
Journal: Annals of the Rheumatic Diseases (2023)

<h3>Background</h3> The efficacy and safety of Xeljanz® have also been confirmed in RA patients. Varieties of generic tofacitinib have been developed in different countries. However, there is no study comparing the efficacy and safety between generic and brand-name tofacitinib yet. <h3>Objectives</h3> In the current study, we compared the efficacy, safety, and cost-effectiveness between a Chinese generic tofacitinib Kelejia® and the brand-name tofacitinib Xeljanz® in RA patients from a prospective real-world cohort. <h3>Methods</h3> RA patients receiving tofacitinib, either generic (Kelejia®, generic group) or branded (Xeljanz®, branded group) were enrolled. All the patients were followed up until the discontinuation of tofacitinib or last visit. Primary outcome was simplified disease activity index (SDAI) defined remission rate at month 6. Secondary outcomes included the rates of remission and low disease activity (LDA) defined by other composite scores; EULAR response rate and ultrasonic synovitis scores at month 1, 3, 6 and 12. Cost-effectiveness was investigated. Propensity score-based inverse probability of treatment weighting (IPTW) was adopted to reduce selection bias. <h3>Results</h3> 204 patients were enrolled, with 59 in generic group and 145 in branded group. The SDAI defined remission was achieved in 41.1% and 39.2% patients in generic group and branded group at month 6, respectively (p=0.854). The rates of remission and LDA achievement, the changes of clinical disease activity scores, power doppler (PD) and gray scale (GS) synovitis scores at months 1, 3, 6 and 12 from baseline were all comparable between two groups. Similar proportions of patients in two groups achieved moderate/good response. Rates of drug retention (78.0% vs 77.2%, p=0.911) and adverse effect (5.1% vs. 4.8%, p=1.000) were also similar in two groups. Both Kelejia® and Xeljanz® were cost-effective, but Kelejia® had lower average cost-effectiveness ratio. <h3>Conclusion</h3> Generic tofacitinib (Keljia®) showed equivalent clinical efficacy and safety, and better cost-effectiveness comparing with its originator (Xeljanz®). Keljia® can be an alternative to brand-name Tofacitinib. <h3>References</h3> [1]Traynor K. FDA approves tofacitinib for rheumatoid arthritis. Am J Health Syst Pharm 2012; 69(24): 2120. [2]van Vollenhoven RF, Fleischmann R, Cohen S, et al. Tofacitinib or adalimumab versus placebo in rheumatoid arthritis. N Engl J Med 2012; 367(6): 508-19. [3]Burmester GR, Blanco R, Charles-Schoeman C, et al. Tofacitinib (CP-690,550) in combination with methotrexate in patients with active rheumatoid arthritis with an inadequate response to tumour necrosis factor inhibitors: a randomised phase 3 trial. Lancet 2013; 381(9865): 451-60. [4]Fleischmann R, Mysler E, Hall S, et al. Efficacy and safety of tofacitinib monotherapy, tofacitinib with methotrexate, and adalimumab with methotrexate in patients with rheumatoid arthritis (ORAL Strategy): a phase 3b/4, double-blind, head-to-head, randomised controlled trial. Lancet 2017; 390(10093): 457-68. [5]Fleischmann R, Kremer J, Cush J, et al. Placebo-controlled trial of tofacitinib monotherapy in rheumatoid arthritis. N Engl J Med 2012; 367(6): 495-507. [6]Lee EB, Fleischmann R, Hall S, et al. Tofacitinib versus methotrexate in rheumatoid arthritis. N Engl J Med 2014; 370(25): 2377-86. <h3>Acknowledgements:</h3> NIL. <h3>Disclosure of Interests</h3> None Declared.